FDA Adverse Event
Malfunction
Summary report: N
SAPPHIRE EPIDURAL INFUSION PUMP SPANISH
MDR report key: 7518282
·
Received May 16, 2018
Report
- Report Number
- 3010293992-2018-00047
- Event Type
- Malfunction
- Date Received
- May 16, 2018
- Date of Event
- May 10, 2018
- Report Date
- May 10, 2018
- Manufacturer
- Q CORE MEDICAL LTD.
- Product Code
- FRN
- UDI-DI
- 07290109150147
- PMA / PMN Number
- K161667
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
(B)(6). (B)(4). EXEMPTION NUMBER, E2014005.
Additional Manufacturer Narrative · 0
DISTRIBUTOR INFORMATION: ICU MEDICAL, INC. US SERVICE CENTER SAN JOSE, CA 95138. EXEMPTION NUMBER: E2014005. Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ICU MEDICAL.
Description of Event or Problem · 0
THE EVENT WAS REPORTED BY A CUSTOMER FROM (B)(6): OVER DELIVERY OF MORPHINE.
Description of Event or Problem · 0
THE EVENT WAS REPORTED BY A CUSTOMER FROM COLOMBIA: OVER DELIVERY OF MORPHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 361686 | SAPPHIRE EPIDURAL INFUSION PUMP SPANISH | INFUSION PUMP | FRN | Q CORE MEDICAL LTD. | 07290109150147 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |